Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis

Phase 3

Completed

Brief Summary: A 12-month study to compare the efficacy and safety of abaloparatide-solid microstructured transdermal system (sMTS) with abaloparatide-subcutaneous (SC).

Detailed Description: This study aims to evaluate the non-inferiority of abaloparatide-sMTS 300 micrograms (mcg) compared to abaloparatide-SC 80 mcg based on lumbar spine bone mineral density (BMD) at 12 months and to evaluate the safety and tolerability of abaloparatide-sMTS in the treatment of postmenopausal women with osteoporosis.

Recruitment & Eligibility

Inclusion Criteria

Healthy ambulatory female from 50 to 85 years of age (inclusive) with postmenopausal osteoporosis
Participants who are 50 to 65 years old with BMD T-score ≤ -2.5 and > -5.0 at the lumbar spine or hip (femoral neck or total hip) by dual energy x-ray absorptiometry (DXA) and meet one of the following: 1) radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures or 2) history of fragility fracture to the forearm, humerus, sacrum, pelvis, hip, femur, or tibia within the past 5 years.
Participants older than 65 years with BMD T score ≤ -2.0 and > -5.0 who meet the fracture criteria may be enrolled
Participants older than 65 years with BMD T score ≤ -3.0 and > -5.0 at the lumbar spine or hip (femoral neck or total hip) by DXA
Body mass index of 18.5 to 33 kilograms (kg)/square meters (m^2), inclusive
serum calcium (albumin-corrected), parathyroid hormone (1-84), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone within the normal reference range
Serum 25-hydroxyvitamin D values must be ≥ 20 nanograms (ng)/milliliters (mL)

Exclusion Criteria

History of more than 4 mild or moderate spine fractures or any severe fracture
Abnormality of the spine or hip that would prohibit assessment of BMD
History of bone disorders other than postmenopausal osteoporosis or a diagnosis of cancer within the last 5 years
History of Cushing's disease, thyroid, parathyroid, or malabsorptive syndromes or any chronic or recurrent diseases or disturbances that would interfere with the interpretation of study data or compromise the safety of the patient
Prior treatment with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
Prior treatment with intravenous (IV) bisphosphonates at any time or oral bisphosphonates within the past 3 years; fluoride or strontium within the past 5 years; treatment with corticosteroids within the past 12 months; or selective estrogen receptor modulators within the past 6 months (except hormone replacement therapy)
Prior treatment with an investigational drug or device within the past 90 days or 5 half-lives of the investigational drug, whichever is longer
History of nephrolithiasis or urolithiasis within the past 5 years or hereditary disorders predisposing to osteosarcoma

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine BMD at Month 12	Baseline, Month 12	Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Hip BMD at Month 12	Baseline, Month 12	Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory.
Percent Change From Baseline in Femoral Neck BMD at Month 12	Baseline, Month 12	Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory.

Locations (95): University of Alabama Hospital at Birmingham
🇺🇸
Birmingham, Alabama, United States
Orthopedic Physician Alaska - Rheumatology
🇺🇸
Anchorage, Alaska, United States
Arizona Arthritis & Rheumatology Research, PLLC - Research Center - Glendale
🇺🇸
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸
Mesa, Arizona, United States
SunValley Arthritis Center Ltd.
🇺🇸
Peoria, Arizona, United States
Clinical Research Consortium
🇺🇸
Tempe, Arizona, United States
Arthritis & Rheumatism
🇺🇸
Jonesboro, Arkansas, United States
Advanced Clinical Research (ACR) - Rancho Paseo
🇺🇸
Banning, California, United States
Osteoporosis Medical Center
🇺🇸
Beverly Hills, California, United States
Clinical Trials of St. Jude Heritage Medical Group through S
🇺🇸
Fullerton, California, United States
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University of Alabama Hospital at Birmingham
🇺🇸Birmingham, Alabama, United States